Assessment of the Effect of a Dermatology-Oriented Spa Therapy on the Quality of Life of Patients With Psoriasis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Spa therapy.
- Who it may be relevant to
- Registry conditions: Psoriasis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Assessment at 4.5 Months of the Effect of a Dermatology-Oriented Spa Therapy on the Quality of Life of Patients With Psoriasis (BAREGES)
Overview
Evaluation of the effect of a dermatology-oriented spa therapy at 4.5 months on the quality of life of patients suffering from psoriasis
Detailed description
BAREGES is a:
prospective, before/after, cohort follow-up study with repeated measurements monocentric study with the dispensation of a 3-week dermatolgy-oriented spa therapy in Barèges
Interventions
- Other Spa therapy
Thermal treatments among the following: Filiform shower, simple bath, aerated bath, general shower, compresses, nebulization inhalation, multiple local mud applications, and drinking cure.
Primary outcome measures
- To evaluate the effect of a complete thermal treatment (moderate impact) for a dermatological indication on the quality of life of patients with psoriasis [Time frame: 4.5 months]
Secondary outcome measures (12)
- To evaluate the effect of a complete thermal treatment (low impact) for a dermatological indication on the quality of life of patients with psoriasis at 4.5 months, taking into account all the care provided [Time frame: 4.5 months]
- To evaluate dermatology-specific quality of life (quantitative DLQI score) [Time frame: 4.5 and 9 months]
- To evaluate overall quality of life using the EQ-5D-5L questionnaire. [Time frame: 4.5 and 9 months]
- To evaluate the clinical improvement of psoriasis in the short and medium term. [Time frame: 4.5 and 9 months]
- To evaluate pain and pruritus. [Time frame: 4.5 and 9 months]
- Physician/Patient perception : The physician's and patient's opinion will be requested to assess the perceived benefit of the treatment. [Time frame: 4.5 and 9 months]
- Medication consumption [Time frame: 4.5 and 9 months]
- Evolution of the general clinical criteria : Body Mass Index (BMI) [Time frame: 4.5 and 9 months]
- Evolution of the general clinical criteria : systolic blood pressure [Time frame: 4.5 and 9 months]
- Evolution of the general clinical criteria : diastolic blood pressure [Time frame: 4.5 and 9 months]
- Evolution of the general clinical criteria : heart rate [Time frame: 4.5 and 9 months]
- Evaluation of the use of care related or not to psoriasis at 4.5 and 9 months [Time frame: 4.5 and 9 months]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years Patient with psoriasis Stable treatment in the last 6 months. DLQI > 10 Patient presenting an indication for thermal treatment focused on dermatology (possible dual orientation).
Patient affiliated to the social security system or such a system Available for an 18-day spa treatment and a 9-month follow-up For women of childbearing age: effective contraception Patient information and informed consent signature
Exclusion criteria
Contraindication to thermal treatment (e.g., ongoing chemotherapy/radiotherapy, uncontrolled progressive neoplasia, progressive heart disease, etc., according to the investigator's assessment) Predictable intolerance to thermal treatments (intolerance to heat, baths, etc.) Patient who has already undergone a dermatology-oriented spa treatment within the current thermal season Subject already included in an interventional clinical research protocol Persons referred to in articles L1121-5 to L1121-8 of the "Code de la Santé Publique" (pregnant women, women in labour and parturient and nursing mothers, persons deprived of liberty by judicial or administrative decision, persons subject to a legal protection measure or not being able to verbally communicate their agreement, minor)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 2 centers
- Centre Hospitalier Victor Dupouy — Argenteuil
- Cabinet Luz Saint Sauveur — Pierrefitte-Nestalas
Publications
- Lebwohl M, Ellis C, Gottlieb A, Koo J, Krueger G, Linden K, Shupack J, Weinstein G. Cyclosporine consensus conference: with emphasis on the treatment of psoriasis. J Am Acad Dermatol. 1998 Sep;39(3):464-75. doi: 10.1016/s0190-9622(98)70325-1. PMID 9738783
- SOLOMON WM, NETHERTON EW, NELSON PA, ZEITER WJ. Treatment of psoriasis with Goeckerman technic. Arch Phys Med Rehabil. 1955 Feb;36(2):74-7. No abstract available. PMID 13229486
- Kazandjieva J, Grozdev I, Darlenski R, Tsankov N. Climatotherapy of psoriasis. Clin Dermatol. 2008 Sep-Oct;26(5):477-85. doi: 10.1016/j.clindermatol.2008.05.001. PMID 18755366
Identifiers
NCT: NCT06735911 · 2024-A00700-47